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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00254514 |
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
Condition | Intervention | Phase |
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Tibia Fractures |
Drug: somatropin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Growth Hormone (Norditropin® SimpleXx®) on Fracture Healing in Tibia Fractures Treated Surgically With Intramedullary Nailing |
Enrollment: | 407 |
Study Start Date: | August 2001 |
Study Completion Date: | October 2003 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN1606-1365 |
Study First Received: | November 15, 2005 |
Last Updated: | June 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00254514 History of Changes |
Health Authority: | South Africa: Medicines Control Council; Israel: Israeli Health Ministry Pharmaceutical Administration; Germany: German Agency of Medicines |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Leg Injuries Tibial Fractures Hormones |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |